| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01285-1 |
| Product Name/Description |
Carestream DRX Evolution with Full Featured Wall Stand, Carestream DRX Evolution with Carestream Premium Wall Stand and Kodak DirectView DR 7500 System with Full FeaturedWall Stand
Serial numbers: 4000 – 5160 and 75000103 - 75000944
ARTG number: 136112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia Pty Ltd has received advice that there were three incidents (one in Australia and two in the United States) where the wall stand (bucky) continued its downward movement despite the radiographer/operator releasing the motorised wall stand (WS) keypad button which controls the downward movement. This can result in the wall stand contacting a patient's legs or feet. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream Australia is conducting a field action to apply a label to remind users of the location of the emergency stop button and to inspect and install a bracing bracket for the motorised wall stand (bucky) keypad or replace keypad if deemed necessary by Carestream's service engineer. |
| Contact Information |
02 8962 4914 - Carestream Health Australia |